RT info:eu-repo/semantics/article
T1 Chiral separation of a basic drug with two chiral centers by electrokinetic chromatography for its pharmaceutical development
A1 Martínez Girón, Ana Belén
A1 Marina Alegre, María Luisa
A1 Crego Navazo, Antonio Luis
K1 Chiral drug
K1 Enantiomeric purity
K1 Chiral stability
K1 Electrokinetic chromatography with cyclodextrins
K1 Química
K1 Chemistry
AB A chiral method using capillary electrophoresis was developed for the separation of the four stereoisomers of a new chiral substance currently undergoing drug development as single enantiomer. After the selection of highly sulfated beta-CD as chiral selector, an exhaustive study on the influence of several experimental variables on the resolution was performed, being the substitution degree of the CD a very decisive factor. Run time and resolutions were about 20 min and higher than 2.0, respectively. The method was validated in terms of selectivity, linearity, accuracy, precision, and limits of detection and quantitation according to the requirements of the International Conference on Harmonisation for the determination of the chiral purity of a drug substance. The usefulness of the method was demonstrated in the control of stereoisomeric impurities in raw material as well as in the determination of the chiral stability of the drug in the solid state and in dosage forms used in safety assessment. Finally, the chiral method was used to investigate the possible in vivo inversion in biological samples. (C) 2016 Elsevier B.V. All rights reserved.
SN 00219673
YR 2016
FD 2016-10-07
LK http://hdl.handle.net/10017/48188
UL http://hdl.handle.net/10017/48188
LA eng
DS MINDS@UW
RD 28-abr-2024